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Human umbilical cord mesenchymal stem cell-derived small extracellular vesicle (hUC-MSC-sEV) eye drops is an investigational biologic therapy being developed for the treatment of dry eye disease (DED). The product consists of small extracellular vesicles (40–160 nm), including exosomes, harvested from human umbilical cord mesenchymal stem cells. These vesicles carry a bioactive cargo of microRNAs (such as miR-21, miR-146a, and miR-100-5p), proteins, and lipids that exert immunomodulatory and regenerative effects on the ocular surface. The mechanism of action involves the suppression of inflammatory signaling pathways, including IRAK1/TAB2/NF-κB and PTEN/PI3K/Akt, and the promotion of M2 macrophage polarization and T regulatory cell induction. It is currently being evaluated in early-phase clinical trials by The First Affiliated Hospital of Xiamen University for both non-Sjögren's and Sjögren's syndrome-associated dry eye.
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